FDA Gives OK to Seven New Cancer Drugs in 1997

Mar 01, 1998

Volume:

7

Issue:

3

ROCKVILLE, Md--The Food and Drug Administration approved 121 new original drugs in 1997 and 431 generic products. Median approval time for new original drugs was shortened by 6%, falling from 15.4 months in 1996 to 14.4 months in 1997.

Femara (letrozole tablets, Novartis Pharmaceuticals Corporation), a once-daily aromatase inhibitor, for use in the treatment of postmenopausal women with advanced breast cancer that has progressed following the use of antiestrogen therapy.

Rituxan (rituximab, IDEC/Genen-tech), the first monoclonal antibody approved for the treatment of cancer in the United States, is a single-agent treatment for follicular, CD-positive, B-cell non-Hodgkins lymphoma. Rituxan is given in four infusions over 22 days.

Neumega (rhIL-11, American Home Products/Genetics Institute), the first biologic approved that promotes platelet production in patients with solid tumors or lymphoma who are undergoing chemotherapy.

Quadramet (samarium Sm 153 lexidronam injection, Cytogen), a radiopharmaceutical for the amelioration of pain from cancers that have metastasized to bone. The agent can be administered as a single intravenous injection on an outpatient basis.

Anzemet (dolasetron mesylate, Hoechst Marion Roussel), a selective

5-HT3 receptor antagonist for the prevention of nausea and vomiting in chemotherapy and surgery patients.